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Recall Observatory FDA recall evidence

Drug product

clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 68180-492-01

D-0377-2025

April 10, 2025

Class II

Product summary

Firm
Lupin Pharmaceuticals Inc.
Event
Event 96681
Status
Terminated
Classification
Class II
Quantity
2724 bottles
Official record key
drug-enforcement:D-0377-2025

Official wording

Reason: Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.

Code information: Lot #: M300442, Exp Date: 6/30/2025

Distribution pattern: USA nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification